Oliceridine-Enhanced Analgesia and Recovery: A G-Protein Biased μ-Opioid Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Oliceridine fumarate low dose: The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.1 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

Oliceridine fumarate high dose: The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.5 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

Oliceridine fumarate moderate dose: The first loading dose of oliceridine fumarate was 1.5 mg in all patients after operation. The PCA dose of the patients was 0.35 mg, and the locking interval was 6 min. A supplemental dose of 0.75 mg is allowed once per hour as needed after 1 h of the load dose

morphine: The first loading dose of morphine was 4 mg in all patients after operation. The PCA dose of the patients was 1 mg, and the locking interval was 6 min. A supplemental dose of 2 mg is allowed once per hour as needed after 1 h of the load dose; The maximum cumulative daily dose is 60 mg.

Study summary

Identifying the lowest effective opioid dose that achieves rapid pain relief while minimizing side effects is a principal objective in postoperative multimodal analgesia strategies. This study aims to determine the optimal analgesic regimen and dosage by assessing the clinical efficacy of oliceridine for postoperative pain management. It also evaluates oliceridine's contribution to accelerated postoperative recovery, examining aspects such as postoperative pulmonary complications, gastrointestinal function, nausea and vomiting, cognitive function, and emotional distress. Furthermore, the study integrates microbiomics and metabolomics to investigate the underlying molecular mechanisms by which oliceridine promotes rapid postoperative recovery. This research will broaden the clinical data and potential applications of oliceridine, addressing gaps in the field and enhancing practical knowledge. Moreover, this is the first time a clinical study combining multiple omics approaches will provide a comprehensive theoretical foundation for its clinical benefits.

Eligibility

Primary outcome measure(s)

• postoperative pain score — 6 hour, 24hour, and 48 hour after surgery
  The NRS Numerical Pain Evaluation Scale assessed postoperative pain status: no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).

Trial sites (1)

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